Class III
Terminated
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.
- Company
- Teva Pharmaceuticals Usa, Inc.
- Recall Initiated
- June 18, 2013
- Posted
- July 24, 2013
- Recall Number
- D-803-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 109,080 Bottles
- Firm Location
- Sellersville, PA, United States
Reason for Recall
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Distribution
Nationwide
Lot / Code Info
Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14
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